Evidence map›Paper›PMID 33005849›Full record

ArticleAnnals of gastroenterological surgery2020

Primary results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Tsutomu Hayashi, Takaki Yoshikawa, Kentaro Sakamaki, Kazuhiro Nishikawa, Kazumasa Fujitani, Kazuaki Tanabe, Kazunari Misawa, Takanori Matsui, Akira Miki, Hiroshi Nemoto and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Annals of gastroenterological surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06798376 (The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06798376 recruitingnot on this mapstarted 2025, after this paper: background citation

The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer

TypeobservationalSponsorChinese PLA General HospitalRan2025 to 2025Enrolled300ConditionsGastric AdenocarcinomaArms≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy, ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy, Gastrectomy
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
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  10. Perioperative TAS-118 plus oxaliplatin in patients with locally advanced gastric cancer: APOLLO-11 study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 2 countries.

Tsutomu HayashiGastric Surgery National Cancer Center Hospital Chuo-ku Japan.ORCID https://orcid.org/0000-0002-9193-8269
Takaki YoshikawaGastric Surgery National Cancer Center Hospital Chuo-ku Japan.ORCID https://orcid.org/0000-0003-1936-9484
Kentaro SakamakiCenter for Data Science Yokohama City University Yokohama Japan.
Kazuhiro NishikawaNational Hospital Organization Osaka National Hospital Osaka Japan.
Kazumasa FujitaniOsaka General Medical Center Osaka Japan.
Kazuaki TanabeGraduate School Hiroshima University Hiroshima Japan.
Kazunari MisawaAichi Cancer Center Hospital Nagoya Japan.
Takanori MatsuiAichi Cancer Center Aichi Hospital Nagoya Japan.
Akira MikiKobe City Medical Center General Hospital Kobe Japan.
Hiroshi NemotoFujigaoka Hospital Showa University Yokohama Japan.
Tetsu FukunagaUniversity Hospital St. Marianna University School of Medicine Kawasaki City Japan.
Yutaka KimuraSakai City Medical Center Sakai Japan.ORCID https://orcid.org/0000-0002-0188-0586
Jun HiharaHiroshima City Asa Hospital Hiroshima Japan.
Aichi Cancer Center · JPNational Cancer Center · USHiroshima City Asa Citizens Hospital · JPHiroshima University · JPKobe City Medical Center General Hospital · JPOsaka National Hospital · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JPShowa University Fujigaoka Hospital · JPSt. Marianna University School of Medicine · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimNeoadjuvant chemotherapy (NAC) is promising to improve the survival of resectable gastric cancer. However, suitable regimen and treatment duration for NAC have not yet been established.

methodsWe conducted a randomized phase II trial to compare two and four courses of neoadjuvant S-1/cisplatin (SC) and S-1/cisplatin/docetaxel(DCS) using a two-by-two factorial design for locally resectable advanced gastric cancer. Patients with M0 and either T4 or T3 in case of junctional cancer or scirrhous-type cancer received two or four courses of SC or DCS. Then, patients underwent D2 gastrectomy and adjuvant S-1 chemotherapy for 1 year. The primary endpoint was 3-year overall survival. The planned sample size was 120 eligible patients.

resultsBetween October 2011 and September 2014, 132 patients were assigned to CS (n = 66; 33 in 2-courses and 33 in 4-courses) and DCS (n = 66; 33 in 2-courses and 33 in 4-courses). The 3-year OS was 58.1% in CS and 60.0% in DCS with hazard ratio of 0.80 (95% CI, 0.48-1.34), while it was 53.1% in the two courses and 65.0% in the four courses with hazard ratio of 0.72 (95% CI, 0.43-1.22). In the survival analysis by duration in each regimen, the 3-year OS was 58.1% for both two and four courses in CS, while it was 48.5% for two courses of DCS and 71.9% for four courses of DCS.

conclusionsConsidering high 3-year OS, four courses DCS has a value to be tested in a future phase III study to confirm superiority of neoadjuvant chemotherapy for locally advanced gastric cancer.

Indexed as

cisplatin/S‐1docetaxel/cisplatin/S‐1gastric cancerneoadjuvant therapy

Identifiers

PMID33005849
PMCPMC7511564
OpenAlexW3043074045

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.